Abstract

Review question/objective The objective of this systematic review is to synthesise the best available evidence on the diagnostic test accuracy (sensitivity and specificity) of Clinical Swallow Assessment (CSA) compared with Video Fluoroscopic Swallow Study (VFSS) in diagnosing oropharyngeal aspiration in children and adults with dysphagia. In this review, VFSS will be the 'Gold Standard' or, reference test and CSA will be the index test. VFSS is the radiographic assessment of swallow function usually performed by a Speech Pathologist and Radiologist. CSA is defined as a non-invasive, non-instrumental assessment of swallow function. It is usually performed by a Speech Pathologist and includes a thorough case history and assessment of oro-motor function. For example, tongue, jaw movement, cough reflex and review of swallow function with a range of food and fluids. A rating is usually provided to describe the level of function and likely presence or absence of aspiration. Based on the CSA findings the Speech Pathologist recommends specific diet and fluid modifications, feeding techniques and positioning techniques to enable safe oral feeding. Inclusion criteria Types of participants Studies will be considered in this review if they include: infants, children or adults with dysphagia. The following definitions will be used within this review: - infant will be defined as < 36 months; - children will be defined as 36 months – 18 years; - adults will be defined as 18 years and over; - dysphagia will be defined as 'a swallowing disorder' 6. The definition uses 36 months as the cut off between infants and children as this is the stage when the infant transitions from sucking patterns used for bottle feeding and early solids and begins to chew solids, self feed and drink from a range of cups consistent with an older child 4. There will be no exclusion of studies based on age or gender. Studies will be excluded that include the population of head and neck cancer (HNC) patients, patients with a tracheostomy in situ and patients with craniofacial anomalies. The primary treatment for HNC patients includes surgery and radiotherapy . Radiotherapy can have a specific impact on swallowing , not necessarily seen in other populations and surgical resections can result in predictable swallowing difficulties . Patients with a tracheostomy in situ and patients with craniofacial anomalies also have known anatomical changes that have a specific impact on swallow function. The clinician undertaking the clinical swallow assessment has access to any anatomical changes following surgery. This is different to other populations whereby information regarding specific neurological and anatomical information is not necessarily available. Focus of the review The focus of this review will be on diagnostic test accuracy (sensitivity and specificity) of Clinical Swallow Assessment (CSA) compared with Video Fluoroscopic Swallow Study (VFSS) in diagnosing oropharyngeal aspiration in children and adults with dysphagia. In this review, VFSS will be the 'Gold Standard' or, reference test and CSA will be the index test. The terms VFSS and Modified Barium Swallow (MBS) refer to the same study. Although this review will use the term VFSS defined as the radiographic assessment of the oral and pharyngeal swallow, MBS studies will also be included. The terms Clinical Swallow Assessment and Bedside Swallow Evaluation also refer to the same diagnostic tool . Clinical Swallow Assessment (CSA) will be used within this review, defined as the non-instrumental, non-radiologic assessment of swallow function by a Speech Pathologist, however studies of Bedside Swallow Evaluation will also be included. Studies that do not use CSA as the index test or do not use VFSS as the reference test will be excluded. In addition, studies of effectiveness, experience or comparison of treatment interventions will be excluded. The diagnostic test accuracy of CSA and VFSS will be compared using: sensitivity and specificity. Where possible, positive and negative predictive values will also be analysed and reported. Sensitivity of a diagnostic test is defined as 'the ability of the test to identify correctly those who have the disease'34. Specificity of a diagnostic test is defined as 'the ability of the test to identify correctly those who do not have the disease' Positive predictive value is defined as the proportion of patients who test positive and actually have the disease in question . Negative predictive value is defined as the proportion of patients who test negative and actually do not have the disease in question .

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